Ostomy surgical procedure comprises severage of the intestine and redirection of the intestinal tract to a stoma, which is formed as an artificial opening in the skin. An annular member may be attached or held against the body so that the stoma is aligned within a central aperture of the member. Matter passing out of the stoma and through the aperture is received in a collection vessel supported from and contained in the annular member.
U.S. Pat. No. 2,324,520 (Lamson) describes an apparatus for closing an abnormal opening in the wall of the anatomy, which apparatus comprises an inflatable blocking member to be positioned within a body channel which member is connected to an outer flange supported on the outside surface of the body wall. In order to close the opening, a detachable syringe can be screwed into a valve which cooperates with the blocking member via a channel passing through the wall. By pumping the syringe, the blocking member can be inflated so as to block the body channel.
United Kingdom patent specification No. 2108848B (Prager) describes a stoma closure device which comprises a plug having a duct therein for allowing the passage of air into an inflatable balloon positioned within the body channel in the abdomen. The inflatable balloon can be inflated by a detachable syringe which must be screwed into a valve positioned in communication with the duct. Closure of the body channel is effected by the sides of the inflatable balloon pressing against the sides of the body channel, which body channel is in turn pressed against an annular ring sutured to the inside of the wall of the abdominal cavity.
The closure devices described in both of the above patent specifications suffer severe drawbacks. One of the main drawbacks is that a separate detachable syringe is required which needs to be carried around by the user. The need to carry around additional equipment for permitting inflation or deflation of the closure device can lead to the transmission of infection to the stoma.
Another difficulty is that the need to attach additional equipment to the closure device in order to open or close the device is inconvenient for the user.
Another serious difficulty with the syringes described in these patent specifications is that it is impossible for the user to know precisely how much to inflate the balloon or blocking member in order to establish an adequate seal on the one hand, and without rupturing the body channel on the other hand. In many cases, the body channel is the intestine and so the consequences of under inflation or over inflation of the balloon or blocking member can be very serious.
Spherical pressure may only minimally increase the bung in size in relation to the force such a bung can exert on the intestinal wall or on the material the bung is made from.
This problem is particularly apparent in the case where the closure device is to be worn by elderly, mentally incapacitated, or disabled people who will not be able to judge the degree of inflation. Even sensitive persons will not be able accurately to estimate the degree of inflation on account of the relative insensitivity of the intestine. Over inflation can lead to excessive pinching of the stomach wall between a support portion of the device positioned on the outside of the wall or between an annular ring, which surrounds the body channel and is sutured onto the inside of the stomach wall, and the inflatable device. Over inflation can lead to rupturing of the relatively weak junction between the body wall and intestine.
These problems become more acute during long-term use of such closure devices, because the pinching between the inflatable balloon and the sutured annular ring or support portion of the device can lead to necrosis.
U.S. Pat. No. 4,210,132 (Perlin) describes various types of artificial sphincters for closure of a channel in a patient's body. An annular member may be placed around the intestine at a location within the skin of the patient. The annular member may comprise a plurality of annular magnets. A plug having an outer wall can be positioned within the stoma, the outer wall extending along the entire length of the plug. Closure of the artificial sphincter is effected by pumping the plug with a fluid so that direct and pressured contact is made along the length of the plug/intestine boundary. Closure is effected by virtue of the pressure exerted by the fluid within the plug on the intestine wall. The efficiency of the closure is determined by the degree/amount of contact area.
This arrangement has the disadvantage that an effective seal is only established because of the forced pressure along the entire wall surface boundary between the plug and the intestine. The device is therefore not able to expand or contract sufficiently in order to accommodate bowel movements at any one place of contact. This is problematic especially in the event of bowel spasms.
U.S. Pat. No. 4,372,308 (Steer et al) describes an ostomy bag formed by welding two sheets of non-rigid, soft, plastic film together around a periphery. The bag includes a filter positioned uppermost thereof, that is, at a position which is a little above the stoma when in situ. One of the walls of the bag has an aperture for connection to a body channel. This device is only a collection device and not a closure device.
The purpose of the filter is to filter flatus generated within the body channel and expelled therefrom. The disadvantage with this arrangement is that expelling of flatus generally occurs under pressure which causes fluid and/or solid material to be ejected outwardly from the opening of the body channel. Spattering of such material is such as to project the fluid or solid material directly into the filter so as to cause blocking thereof.
USSR patent No. 1199245 (Belo Gen) describes an alternative filter arrangement for a stoma closure. In this arrangement, a closure device comprises a plug portion which is inserted into the opening, and a head portion which extends along the surface of the patient's exterior wall. A filter material is positioned between a head portion and the wall so as to filter flatus emerging from the stoma.
This arrangement suffers from the disadvantage that the filter quickly becomes blocked owing to fluid and/or solid material emerging from the stoma and immediately blocking the filter thereby preventing expelling of flatus and causing discomfort for the patient.
It is an object of the present invention to overcome the aforementioned problems and to provide a neater, simpler, safer, more comfortable and convenient closure device for body channels.
In particular, it is an object of the present invention to provide a closure device which can be opened by means of inflation or deflation of an inflatable member positioned within the body channel, which means for inflating or deflating the devices is integral with the device and is configured to prevent over or under inflation thereof.
It is a further object of the present invention to provide an inflatable member which can provide an effective seal without exerting excessive pressure on the internal walls of the body channel.
It is a further object of the present invention to provide a filter arrangement for a closure device, which filter arrangement is less prone to becoming blocked, and a closure device which can be coupled to a collection device for collecting waste products from a body channel.